This invention relates to a method for making a solution containing a composition for optimizing the environmental conditions within the human oral cavity and more particularly to a clear, stable aqueous solution containing a composition for remineralizing teeth and for improving the function of the oral leucocytes and to a method of preparing the same.
It has been heretofore known to utilize various solutions to aid in remineralizing teeth that have caries lesions in them and to enhance mineralization of normal teeth so they are much less likely to get caries. Because of the presence of calcium ions and phosphate ions in these solutions and the affinity of these ions for each other with the accompanying precipitation of calcium phosphate salt from solution, it is necessary to maintain these materials in separate containers until shortly prior to use. This requirement substantially renders the concept impractical as an item for consumer sales because it necessitates mixing proportionate amounts of each ingredient immediately prior to use. The public generally avoids products having this type of requirement. (See "Continuing Evaluation of the Use of Fluorides" AAAS Selected Symposium 11, Published by Westview Press, Inc., 5500 Central Ave., Boulder, Colo. 80301.)
U.S. Pat. No. 4,024,237, discloses chemical formulations (four illustrative formulations are included) which are comprised of non-toxic ingredients which favor and promote oral leucocyte function, including locomotion, phagocytosis and protoplasmic function resulting in the control and kill of bacteria (col. 3, lines 12-16). It is proposed that oral diseases such as periodontal disease and perhaps dental caries can be controlled and treated, especially early periodontal disease (col. 3, lines 16-21). The compositions of this patent contain non-toxic ingredients for four principal purposes:
(1) Maintaining a colloidal and viscous environment within the oral cavity which favors and promotes oral leucocyte locomotion, phagocytosis, and bacterial kill.
(2) Providing the oral leucocytes with a suitable source of energy when needed.
(3) Providing and maintaining a balanced ionic environment which favors and promotes locomotion, phagocytosis, and bacterial kill.
(4) Maintaining substantially a physiological pH in order to promote leucocyte functions while avoiding other tissue and cell injury (col. 3, lines 23-25).
The patent contains descriptions of studies which show that use produced increased numbers of healthy oral leucocytes which can be harvested, enhanced the number of oral leucocytes which showed bacterial killing ability, and produced a dramatic improvement of a periodontal disease (gingivitis) in subjects who used a formulation of the patent applied by themselves (col. 7 to col. 11, line 56).
U.S. Pat. No. 4,283,385 discloses dentrifrice preparations having incorporated therein ethylenediamine tetraacetic acid and the sodium salts thereof. Also employed in the dentrifrice are abrasives such as calcium, carbonate and various calcium phosphates. These are employed generally in amounts of from about 5% to about 60% by weight. The minor amount of ethylenediamine tetracetic acid brings about the inhibition of the inactivation of soluble fluoride by the calcium containing abrasives.
U.S. Pat. Nos. 4,183,915 and 4,177,258 disclose a stable aqueous remineralizing solution having a source of calcium ions and phosphate ions sufficient to effect remineralization, a fluoride providing agent and a phosphorous containing antinucleating agent which absorbs onto a spherical nucleated particle of hydroxyapatite as it forms and entirely blocks crystal growth. The stable remineralizing solution is prepared by adding the calcium ion and phosphate ion sources to water and lowering the pH to keep the solution clear.
An article by Meyer and Nancollas entitled "The Influence of Multi-Dentate Organo-Phosphonates on the Crystal Growth of Hydroxyapatite." Calc. Tiss. Res., 13:295-303 discusses the rate of crystal growth of hydroxyapatite seed crystals in stable supersaturated solutions of calcium phosphate in the presence of organic phosphorates. The most effective of the phosphorates, N, N, N.sup.1, N.sup.1 ethylenediamine-tetra (methyline phosphonic acid) is structurally similar to ethylenediamine tetraacetic acid and would also be expected to be a good chelating agent for calcium ions situated at crystal surfaces.
It is an important consideration when dealing with prophylactic and therapeutic compositions for treatment of the human oral cavity, that users of these compositions can apply them at their own convenience without an appreciable amount of preparatory effort or the supervision of medically trained personnel. Further, the composition must be non-toxic in substantially all amounts if the objective is to make these compositions freely available to the general public.
It is therefore an object of this invention to provide an improved method of preparing a solution containing a composition capable of being stored in a single container, for optimizing the environmental conditions within the human oral cavity and the solution made by a said method.
It is another object of this invention to provide an improved mouthwash solution and a method of preparing said solution maintainable as a one bottle solution capable of remineralizing caries lesions in the teeth and mineralizing normal teeth to prevent caries from forming.
It is a further object of this invention to provide an improved solution and a method of preparing said Composition maintainable as a one bottle solution to stimulate the white cells present in the oral cavity to act as a protective mechanism to prevent periodontal disease or treat it if already in existence.
It is still a further object of this invention to provide an improved a method of preparing said solution capable of achieving the advantages of both of the two previously stated objectives.
It is a still further object of this invention to provide an improved method of preparing an oral lavage solution which reduces or eliminates mouth odor.